Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07410156

Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods.

The present study will be carried to evaluate the efficacy of MN technique with topical Silymarin application in treating gingival hyperpigmentation in comparison with Laser and scalpel methods. This evaluation will be done clinically. The questions to be answered:

* Is there a statistical difference between the microneedling (MN) technique with topical silymarin application, the scalpel technique, and the diode laser in providing clinical and aesthetic advantages in the treatment of gingival pigmentation? * What medical problems do participants have when using of Silymarin topically?

Participants will be:

Group 1 : The gingiva of the facial surfaces of the selected area will be de-epithelized by conventional method through blades no 15c.

Group 2 : The gingiva of the facial surfaces of the selected area will be de-epithelized by A Diode laser Device (serolaser).

Group 3 : The gingiva of the facial surfaces of the selected area will be treated by repetitive punctures with Dr.Pen ULTIMA - A6 needle tip. Silymarin is applied topically for ten minutes.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gingival Pigmentation Gingival Hyperpigmentaion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fayoum University, Faculty of Dentistry, Department of Oral Medicine and Periodontology

Al Fayyum, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients will be free from any systemic diseases according to criteria of Modified Cornell Medical Index
  • Patient with physiologic pigmentation
  • Non smoker
  • Patient agree to sign the written consent
  • Both genders

Exclusion criteria

  • Pregnant and lactating women
  • Systemic conditions affect melanin production
  • Medications induce pigmentation or enlargement
  • Those with known allergies to silymarin.

Treatment and study plan

Gingival Depigmentation with Conventional Method

Procedure

Under aseptic conditions and infiltration anaesthesia, The gingiva of the facial surfaces of the selected area will be de-epithelized by using the blade till complete removal of the depigmented tissue reached method through blades no 15c till the entire pigmented area is resolved.

Other names: Scalpel depigmentation

Gingival Depigmentation with Diode Laser

Procedure

Under aseptic conditions and infiltration anaesthesia, The gingiva of the facial surfaces of the selected area will be de-epithelized by A Diode laser Device (serolaser) in a free running pulse mode. Remnants of the ablated tissue will be removed using sterile gauze dampened with saline. The procedure will be performed from a cervico-apical direction in all pigmented areas

Other names: Laser depigmentation

Gingival Depigmentation with Microneedling and Silymarin Application

Procedure

Under aseptic conditions and infiltration anaesthesia, The gingiva of the facial surfaces of the selected area will be treated by repetitive punctures with Dr.Pen ULTIMA - A6 needle tip. The needle tip features six speed settings, ranging from 412 to 700 cycles per minute, with 12-24 needles arranged in rows. Healthcare professionals can treat areas in back and forth motion for 30- 40 seconds. Changing the needle length is simple with guides. Using the same handpiece for several patient applications is made possible by disposable needletips. Silymarin is applied topically for ten minutes.

Primary outcomes

  1. Gingival Pigmentation Recurrence

    Time frame: From the enrollment till 6 months

    Visual assessment will be the way to measure how the gingiva is depigmented through DOPI score from 1 ( no pigments ) to 4 ( maximum pigments )

Secondary outcomes

  1. post-operative pain

    Time frame: pain will recoreded at 1,3,5,7days after the treatment ( from intervention till 1 week )

    VAS ( visual analogue scale ) from 0 ( no pain ) to 10 ( severe pain )

Other outcomes

  1. Wound Healing

    Time frame: wound healing will recorded at 7,14,30 days postoperative ( from enrollment till 4 weeks )

    Wound healing index Score 1 : Uneventful healing with no gingival oedema, erythema, suppuration, patient discomfort, or flap dehiscence Score 2 : Uneventful healing with slight gingival oedema, erythema, patient discomfort, or flap dehiscence, but no suppuration Score 3 : Poor wound healing with significant gingival oedema, erythema, patient discomfort, flap dehiscence, or any suppuration

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods. A Randomized Clinical Trial

Acronym: Depigmentation

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.